Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS) | NCT00280631

Studies
Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

NCT00280631

Sponsor

Telik

Status

Completed

Last Update Posted

May 31, 2012Estimated

Enrollment

49Actual

Phase

Phase 1Phase 2

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

Ezatiostat Hydrochlorine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Mar 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 19, 2006

First Submission Date that Met QC Criteria

Jan 19, 2006

First Posted Date

Jan 23, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2012

Last Update Posted Date

May 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)

Detailed Description

This Phase 1-2a study is an open label, dose-ranging study of TLK199 Tablets in patients with all World Health Organization or French-American-British classification types of myelodysplastic syndrome (MDS). In Phase 1, the safety, pharmacokinetics, and hematologic response rate with TLK199 Tablets will be evaluated. The Phase 1 dose-ranging stage is designed to determine the maximum tolerated dose or optimal biologic dose of TLK199 Tablets. Evaluation of the pharmacokinetics of TLK199 Tablets will be conducted. In Phase 1, an additional 12 patients will undergo pharmacokinetic evaluation under fed conditions at the selected Phase 2a dose. In Phase 2a, further safety and hematologic responses by the modified International Working Group MDS response criteria will be studied.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day	Drug: Ezatiostat Hydrochlorine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ezatiostat Hydrochlorine	Drug	Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose or Optimal Biologic Dose		6 months

Secondary Outcomes

Measure	Description	Time Frame
Safety Pharmacokinetic Parameters, Hematologic Response Parameters		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of MDS
Documented significant cytopenia for at least 2 months
Adequate liver and kidney function
Ineligible for stem cell bone marrow transplantation
At least 18 years of age
Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry

Exclusion Criteria:

Prior bone marrow transplant
Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry
Pregnant or lactating women
Other investigational drugs within 14 days of study entry
Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gail Brown, MD	Telik	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loyola University Chicago-Cardinal Bernardin Cancer Center		Maywood	Illinois	60153	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19398716	Derived	Raza A, Galili N, Smith S, Godwin J, Lancet J, Melchert M, Jones M, Keck JG, Meng L, Brown GL, List A. Phase 1 multicenter dose-escalation study of ezatiostat hydrochloride (TLK199 tablets), a novel glutathione analog prodrug, in patients with myelodysplastic syndrome. Blood. 2009 Jun 25;113(26):6533-40. doi: 10.1182/blood-2009-01-176032. Epub 2009 Apr 27.

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases